NCT04283994: PICSI-H

Project to Improve Communication About Serious Illness--Hospital Study: Comparative Effectiveness Trial (Trial 2)

Completed NA Results posted Last updated 24 June 2025

What this trial tests

NA trial testing Survey-based Patient/Clinician Jumpstart in Dementia in 756 participants. Completed in 27 January 2025.

Timeline

26 July 2021

Primary endpoint
1 December 2023

27 January 2025

Quick facts

Lead sponsor	University of Washington
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	756
Start date	26 July 2021
Primary completion	1 December 2023
Estimated completion	27 January 2025
Sites	3 locations across United States

Drugs / interventions tested

• Survey-based Patient/Clinician Jumpstart
• EHR-based Clinician Jumpstart

Conditions studied

• Dementia — all drugs for Dementia →
• Chronic Disease — all drugs for Chronic Disease →
• Neoplasm Metastasis — all drugs for Neoplasm Metastasis →
• Lung Neoplasms — all drugs for Lung Neoplasms →

Sponsor

University of Washington

Who can join

18 and older, any sex, with Dementia or Chronic Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

EHR Documentation of Goals of Care Discussions Primary · from randomization to 30 days post randomization

The primary outcome is the proportion of patients who have a goals-of-care discussion that has been documented in the electronic medical record (EHR) in the period between randomization and 30 days following randomization. The proportion is the number of patients with goals-of-care (GOC) documentation over the number of patients in each study arm. Documentation of goals-of-care discussions will be evaluated using our natural language processing/machine learning (NLP/ML) methods.

Group	Value	95% CI
Survey Based Bi-directional Jumpstart Guide Intervention	0.271
EHR Based Clinician-facing Jumpstart Guide Intervention	0.317
Usual Care: No Intervention	0.206

Intensity of Care: ICU Admissions (30 Days) Secondary · from randomization to 30 days post randomization

Any new ICU admissions or readmissions collected from the EHR.

Group	Value	95% CI
Survey Based Bi-directional Jumpstart Guide Intervention	0.0887	± 0.302
EHR Based Clinician-facing Jumpstart Guide Intervention	0.0634	± 0.282
Usual Care: No Intervention	0.0622	± 0.279

Intensity of Care: ICU Admissions (90 Days) Secondary · from randomization to 90 days post randomization

Any new ICU admissions or readmissions collected from the EHR.

Group	Value	95% CI
Survey Based Bi-directional Jumpstart Guide Intervention	0.118	± 0.367
EHR Based Clinician-facing Jumpstart Guide Intervention	0.117	± 0.391
Usual Care: No Intervention	0.0957	± 0.354

Intensity of Care: ICU Admissions (Post-discharge, 7 Days) Secondary · 7-days post-discharge

Any ICU admissions or readmissions collected from the EHR. Censored at 90 days post-randomization.

Group	Value	95% CI
Survey Based Bi-directional Jumpstart Guide Intervention	0.015	± 0.121
EHR Based Clinician-facing Jumpstart Guide Intervention	0.010	± 0.099
Usual Care: No Intervention	0.000	± 0.000

Intensity of Care: ICU Admissions (Post-discharge, 30 Days) Secondary · 30-days post-discharge

Any ICU admissions or readmissions collected from the EHR. Censored at 90 days post-randomization.

Group	Value	95% CI
Survey Based Bi-directional Jumpstart Guide Intervention	0.030	± 0.170
EHR Based Clinician-facing Jumpstart Guide Intervention	0.034	± 0.207
Usual Care: No Intervention	0.024	± 0.153

Intensity of Care: Hospital Readmissions (7 Days) Secondary · readmissions in 7 days following discharge

Any hospital readmissions in 7 days following discharge; collected from the EHR. Censored at 90 days post-randomization.

Group	Value	95% CI
Survey Based Bi-directional Jumpstart Guide Intervention	0.0394	± 0.195
EHR Based Clinician-facing Jumpstart Guide Intervention	0.0732	± 0.261
Usual Care: No Intervention	0.0766	± 0.267

Intensity of Care: Hospital Readmissions (30 Days) Secondary · readmissions in 30 days following discharge

Any hospital readmissions in 30 days following discharge collected from the EHR. Censored at 90 days post-randomization.

Group	Value	95% CI
Survey Based Bi-directional Jumpstart Guide Intervention	0.128	± 0.335
EHR Based Clinician-facing Jumpstart Guide Intervention	0.176	± 0.463
Usual Care: No Intervention	0.230	± 0.475

Intensity of Care: ICU Free Days (30 Days) Secondary · from randomization to 30 days post randomization

Number of days alive and out of the ICU within 30 days from randomization, collected from the EHR.

Group	Value	95% CI
Survey Based Bi-directional Jumpstart Guide Intervention	28.1	± 5.81
EHR Based Clinician-facing Jumpstart Guide Intervention	27.9	± 6.17
Usual Care: No Intervention	28.5	± 4.72

Intensity of Care: ICU Free Days (90 Days) Secondary · from randomization to 90 days post randomization

Number of days alive and out of the ICU within 90 days from randomization, collected from the EHR.

Group	Value	95% CI
Survey Based Bi-directional Jumpstart Guide Intervention	83.8	± 19.3
EHR Based Clinician-facing Jumpstart Guide Intervention	79.9	± 24.3
Usual Care: No Intervention	83.1	± 19.5

Intensity of Care: Hospital Free Days (30 Days) Secondary · from randomization to 30 days post randomization

Number of days alive and out of the hospital within 30 days from randomization; collected from the EHR.

Group	Value	95% CI
Survey Based Bi-directional Jumpstart Guide Intervention	21.6	± 8.42
EHR Based Clinician-facing Jumpstart Guide Intervention	20.8	± 9.16
Usual Care: No Intervention	20.8	± 8.51

Intensity of Care: Hospital Free Days (90 Days) Secondary · from randomization to 90 days post randomization

Number of days alive and out of the hospital within 90 days from randomization; collected from the EHR.

Group	Value	95% CI
Survey Based Bi-directional Jumpstart Guide Intervention	75.2	± 21.6
EHR Based Clinician-facing Jumpstart Guide Intervention	70.5	± 26.6
Usual Care: No Intervention	71.6	± 24.4

Patient or Surrogate/Family-reported Discussion of Goals (3-5 Days) Secondary · 3-5 days after randomization

Subjects will self-report (yes or no) if they had a discussion of goals of care ("the kind of medical care you/your loved one would want") during the index hospitalization. Responses of "unsure" are included in the sample and not counted as missing. This outcome is presented as a proportion: the number of participants reporting a goals-of-care discussion over the number of patients in each study arm.

Group	Value	95% CI
Survey Based Bi-directional Jumpstart Guide Intervention	48
EHR Based Clinician-facing Jumpstart Guide Intervention	39
Usual Care: No Intervention	62

Sponsor's own description

The objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over time, and across settings and providers. This study is particularly interested in understanding the effect of the intervention to improve quality of palliative care for patients with Alzheimer's disease and related dementias (ADRD) but will also include other common chronic, life-limiting illnesses.

The specific aims are:

1. To evaluate the efficacy of the EHR-based clinician-facing Jumpstart, drawn from the electronic medical record (EHR), the survey-based bi-directional Jumpstart, drawn from patient or family completed surveys, and usual care for improving quality of care provided to patients with chronic illness experiencing a hospitalization. The primary outcome is EHR documentation of a goals-of-care discussion, assessed from randomization through 30 days. Secondary outcomes include: a) intensity of care outcomes (e.g., ICU use, ICU and hospital free days, hospital readmissions, costs of hospital care); and b) patient- and family-reported outcomes assessed by surveys at 3-5 days and 4-6 weeks after randomization, including occurrence and quality of goals-of-care discussions in the hospital, goal-concordant care, psychological symptoms, and quality of life.
2. To conduct a mixed-methods evaluation of the implementation of the interventions, guided by the RE-AIM and CFIR frameworks for implementation science, incorporating quantitative evaluation of the interventions' reach and adoption, as well as qualitative analyses of interviews with participants, to explore barriers and facilitators to future implementation and dissemination.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A modular pipeline for natural language processing-screened human abstraction of a pragmatic trial outcome from electronic health records.
   Lee RY, Li KS, Sibley J, Cohen T, et al · · 2026 · PMID 41680079 · DOI 10.1177/17407745251405386
2. Corrigendum to "Improving communication about goals of care for hospitalized patients with serious illness: Study protocol for two complementary randomized trials"[Contemporary Clinical Trials 2022;120:106879].
   Curtis JR, Lee RY, Brumback LC, Kross EK, et al · · 2025 · PMID 40373357 · DOI 10.1016/j.cct.2025.107944